MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number NV UNK PIPELINE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Kühn, a.L., wakhloo, a.K., gounis, m.J., kan, p., de macedo rodrigues, k., lozano, j.D., marosfoi, m.G., perras, m., brooks, c., howk, m.C., rex, d.E., massari, f., <(>&<)> puri, a.S.(2017).Use of self-expanding stents for better intracranial flow diverter wall apposition.Interventional neuroradiology¿: journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences, 23(2), 129¿136.Https://doi.Org/10.1177/1591019916681981.Medtronic review of the literature article found described 5 cases in which pipeline devices were implanted for aneurysm treatment.In 3 of the cases wall apposition was inadequate.In 2 cases proximal migration occurred and was attributed to challenging patient anatomy.In all cases a non-medtronic self-expanding nitonol stents were subsequently deployed for improving wall apposition and jail the pipeline stents from further migration respectively.During one procedure, a clot developed after stent deployment and the patient was immediately treated successfully with glycoprotein iib/iiia inhibitor.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12439439
• MDR Text Key: 270346676
• Report Number: 2029214-2021-01125
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR